The Channel A COOK NEWS PUBLICATION. with COOK MEDICAL

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1 MEDICAL The Channel A COOK NEWS PUBLICATION ISSUE 02 // 2018 with COOK MEDICAL Cook Medical: 20 years of innovation in EUS In 1998 at the annual DDW Congress, Cook Medical s Endoscopy division (known then as Wilson-Cook Endoscopy) launched the ground-breaking EchoTip Endoscopic Ultrasound Needle. Created in collaboration with some of the world s leading gastroenterologists, the EchoTip brought EUS-guided fine needle aspiration technology to a large, global patient population. Now, endoscopists had a less-invasive method to reach suspicious GI lesions and adjacent organs including the liver, bile ducts and pancreas and an enhanced ability to diagnose many different types of GI malignancies. Continued on next page.

2 As interventional EUS continues to evolve, further expansion into previously uncharted areas will most certainly occur. New potential exists for developments in a variety of EUS-guided therapeutic modalities. all of which points to a robust future for this modality. At Cook, we plan to continue to be an EUS leader by remaining firmly committed to maintaining our role as innovators in shaping that bright future. Barry Slowey Physician collaboration refines prototypes The EchoTip had its beginnings in 1992, said Rhonda Schlotfeldt, Research and Development Specialist, Prototype/Feasibility Developer. That was when members of the our original EUS team began the design work and hand-building early prototypes by attaching one of the company s Howelltype aspiration needles to the tip of a long plastic catheter that could be passed through the linear scope. Cheri Matney, Senior Process Engineering Technician, who was on the EUS team, was invaluable. She built a ton of prototypes, Schlotfeldt said. We then sent those out to our GI endoscopy thought leaders around the world and, in some cases, travelled to meet and work with the clinicians in person. Incorporating the feedback from those physicians, said Schlotfeldt, we worked our way through multiple iterations of the FNA needle and refined the device in a relatively short timeframe. That s how devices evolved in the early days. Meeting the manufacturing challenges Once the design had been firmly established, it was time to begin mass producing the EchoTip. One of the biggest production challenges, said Cook s Production Engineering Manager Scott Moore, was applying hundreds of dimples to the tip of each needle for added echogenicity. Each dimple was roughly three-thousandths of an inch in diameter not much larger than a human hair. The Endoscopy division addressed the dimpling challenge by collaborating with another Cook Medical division for help. We acquired a dimpling machine from Cook Urological that they used for their needles, said. Moore. (See page 3.) At that time, it was a state-of-theart machine. And, while it was a pretty neat process that it was performing, the machine s components weren t really that robust. Later on, we created a new machine that increased production efficiencies and, most importantly, increased the number of dimples in the needle design, greatly enhancing echogenicity. continued on page 3 2 cookmedical.com

3 UNITED STATES Combining histology and cytology influences patient treatment A 48-year-old patient with a pancreatic mass on CT presented for further evaluation with endoscopic ultrasound (EUS). EUS revealed an iso-echoic solid tumor, measuring 23 x 14 mm, in the body of the pancreas. Subsequent EUS-guided fine needle aspiration biopsy was performed with a 25 gauge biopsy needle (Cook Medical 25 gauge EchoTip ProCore) (Figure 1). Based on this precise tissue diagnosis, the patient underwent surgery with successful resection of the tumor. Kenneth Chang, MD Executive Director H. H. Chao Comprehensive Digestive Disease Center University of California-Irvine Dr. Kenneth Chang is a paid consultant of Cook Medical. Macrosopic evaluation of specimen showed whitish core tissue (Figure 2). The core specimen was transferred into a formalin bottle for histological processing. The remainder of the non-core specimen was smeared and submitted for cytology. On-site cytological analysis showed adequate specimen on Diff-Quik stain (Figure 3). Histological analysis of the core specimen showed pancreatic neuroendocrine tumor on H.E. stain (Figure 4). Immunohistochemical staining with Chromogranin A and Synaptophysin (Figure 5) confirmed the diagnosis. Figure 1 Figure 3 Figure 2 Figure 4 Figure 5 continued from page 2 The next 20 years and beyond The EchoTip Endoscopic Ultrasound Needle was just the beginning of Cook s foray into EUS. From EUSguided celiac plexus block and core biopsy, from access and injection to fiducial marker placement Cook has created a continually evolving assortment of EUS clinical solutions to help physicians more effectively treat their patients. As interventional EUS continues to evolve, further expansion into previously uncharted areas will most certainly occur, said Barry Slowey, president of Cook Winston-Salem and vice president of Cook Medical s endoscopy specialty. New potential exists for developments in a variety of EUS-guided therapeutic modalities, as well as EUS-enabled vascular assessment and intervention all of which points to a robust future for this modality. At Cook, we plan to continue to be an EUS leader by remaining firmly committed to maintaining our role as innovators in shaping that bright future. cookmedical.com 3

4 EchoTip ProCore 20 gauge EUS needle balances flexibility and sample size Cook Medical collaborated with practicing endosonographers who require devices with ever-advancing clinical capabilities. It began with the first contoured handle on the market, followed by patented, high-definition dimpling technology for enhanced needle visualization. Cook pioneered the EchoTip ProCore, which merges histology and cytology, allowing clinicians to increase yields with potentially fewer needle passes. Soon, however, practitioners began requesting EUS needles that can obtain quality histology samples without sacrificing needle flexibility. On the one hand, the FNA needles, in particular the 25 gauge, is very easy to handle but the amount of tissue that one gets with that needle is relatively limited and also, of course, it s cytology material, said Prof. Marco Bruno, MD, PhD, Erasmus Medical Center, Gastroenterology & Hepatology Department, Rotterdam, Netherlands. Whereas, with the ProCore needle, you re able to get histological materials but the drawback is that the larger size needles are difficult to handle and a little bit stiff. The desire by practitioners for increased needle flexibility without diminished sampling capacity led Cook s engineers and researchers to create the 20 gauge EchoTip ProCore. This needle gives endosonographers a tool with the flexibility to accurately target small lesions while increasing valuable histological yields. The Cook 20 gauge EchoTip ProCore offers improved flexibility for those more difficult EUS-FNA biopsy approaches, with easy to-and-fro passage of the needle, along with a larger 20 gauge needle to yield histologic grade tissue for both diagnosis and ancillary studies, said James Farrell, MD, Interventional Endoscopy and Pancreatic Diseases Section of Digestive Diseases, Yale University School of Medicine. According to Prof. Marc Giovannini, MD, PhD, Endoscopic Unit, Paoli-Calmettes Institute Marseilles, France: Cytology is not enough in the diagnosis and treatment of all lesions. You need sufficient quality of material to correctly characterize tumors and conditions. The [20 gauge] EchoTip ProCore needle is a good compromise between the ease of use of a small needle and the quality of sample you can achieve with a bigger needle. Inspiring clinical research: Histology vs. cytology Like many medical device innovations, the ProCore 20 gauge has already inspired important clinical research. The study titled: A Multicenter Trial, Comparing a 25G EUS Fine Needle Aspiration (FNA) Device With a 20G EUS ProCore Fine Needle Biopsy (FNB) Device (ASPRO) includes global participation by pathologists and will examine the histologyversus-cytology question. There has long been a lack of consensus amongst global pathologists as to when cytology is adequate and when histology information is also needed, Prof. Bruno said. Theoretically, one would assume pathologists would prefer histological materials, not only because it s better to handle, more easy for them, but also because they re used to handling histological materials, particularly in peripheral clinics. In academics perhaps, pathologists are used to handling cytology material. But, in particular, in the community hospitals, pathologists are used to histological material. I think what s very interesting about this particular study is that we re going to compare the specimens we get from FNA and from FNB then blind the pathologists so that they truly are interpreting only the specimen sample that they see before them. For more information about the 20 gauge EchoTip ProCore please contact your local sales representative. Prof. Marco Bruno and Dr. Marc Giovannani are paid consultants of Cook Medical Dr. James Farrell is not a paid consultant of Cook Medical. 4 cookmedical.com

5 NETHERLANDS First experience with the 20 gauge EchoTip ProCore FNB needle: Diagnosis and staging of a pancreatic neuroendocrine tumor Priscilla van Riet, MD Gastroenterology and Hepatology Erasmus MC University Medical Center Rotterdam, The Netherlands Background Pancreatic neuroendocrine tumors (p-net) comprise an intriguing disease entity posing clinicians with some interesting differential diagnostic challenges. Currently available imaging techniques can identify p-nets in most cases, but histological confirmation is required to select the best management strategy. EUS-guided tissue sampling is the procedure of choice for preoperative tissue collection in p-nets. To obtain a reliable diagnosis, pathologists require a tissue sample of sufficient size and quality that allows for the full range of diagnostic tests. Importantly, sample adequacy is influenced by several factors, including the type of device and sampling technique used. Introduced in late 2015, the 20 gauge EchoTip ProCore FNB needle is designed to combine the best features of currently available sampling tools; a large core size for optimal histological tissue acquisition, yet easy to be handled in anatomically challenging locations because it has a flexibility that approximates that of a 25 gauge needle. We share our first experience with the ProCore FNB device in diagnosing and staging a pancreatic neuroendocrine tumor. Case A 73-year-old patient was referred to our outpatient department with complaints of weight loss (13 kg in 2 years), flushes and intermittent epigastric pain. The patient s medical history reported hypertension and de novo diabetes since Previously, the patient had undergone an abdominal CT scan, which showed a hypodense, nodular lesion in or near the head of the pancreas (Figure 1). Figure 1 Abdominal CT scan with contrast enhancement, showing a hypervascular, nodular lesion near the head of the pancreas (arrows). Dr. Priscilla van Riet is a paid consultant of Cook Medical. cookmedical.com 5

6 NETHERLANDS Because of the suspicion of either a neuroendocrine tumor or enlarged peripancreatic lymph nodes, the patient was scheduled for EUS-guided tissue sampling under conscious sedation in an outpatient setting. On EUS, a hypoechogenic, hypervascular, contrast-enhancing lesion (9 x 12 mm) was observed, located in the head of the pancreas (Figure 2). The patient had EUS-guided tissue sampling using the 20 EchoTip ProCore FNB needle. Figure 2 EUS procedure, showing a hypoechogenic mass (9 x 12 mm) between the pancreatic head and the uncinate process with sharp margins, before insertion of the FNB needle. Figure 3a Histology of a 20 gauge Echotip ProCore FNB biopsy. H&E staining of the tissue core showing nests of tumor cells imbedded in fibrous stroma. The lesion was punctured from the duodenum (D2) and three consecutive needle passes were performed, using suction with a syringe. Excellent tissue samples were obtained from all three passes. Each pass contained both tissue cores and material for cytology. Immunohistochemical staining was performed (Figure 3a and 3b) and found positive for Pancreatin, CD 56, Synaptophysin, Chromogranin A, and the somatostatin receptor SSTR-2a. A proportion of mitotic cells between 3-20% (MIB-1 or Ki67) confirmed a pancreatic neuroendocrine tumor, grade 2. Conclusion In this patient with a neuroendocrine tumor in the head of the pancreas, the 20 gauge EchoTip ProCore FNB needle provided a reliable tissue diagnosis to guide further management. The 20 gauge EchoTip ProCore FNB needle is part of a large scale international study (ASPRO study) of which the results are eagerly awaited. Figure 3b Synoptophysin immunohistochemistry with strong positivity of tumor cells. Magnification x200. The final diagnosis is a neuroendocrine tumor in the head of the pancreas, grade 2. Clinical images courtesy of Priscilla van Riet, MD, Erasmus MC University Medical Center, Rotterdam, The Netherlands 6 cookmedical.com

7 UNITED STATES EUS-guided fiducial placement Endoscopic ultrasound capabilities continue to evolve and to increasingly optimize the goals of therapeutic intervention. One example of this is the growing impact of image-guided radiation therapy (IGRT) which is enabled by fiducial marker placement. Dr. Douglas Adler, Professor of Medicine at the University of Utah School of Medicine and Director of Therapeutic Endoscopy, states that EUS-guided fiducial placement helps radiation oncologists precisely target tumors, lymph nodes and other lesions of concern. More precise therapy often means lower dosages of radiation overall, which is usually better for the patient. Dr. Adler leads off one of two case reports, which includes procedural experiences with Cook Medical s recently introduced pre-loaded EchoTip Ultra Fiducial Needle. EUS-guided fiducial placement helps radiation oncologists precisely target tumors, lymph nodes and other lesions of concern. More precise therapy often means lower dosages of radiation overall, which is usually better for the patient. Douglas G. Adler MD, FACG, AGAF, FASGE Professor of Medicine Director of Therapeutic Endoscopy University of Utah School of Medicine Huntsman Cancer Hospital Salt Lake City, UT Presentation A 64-year-old patient developed midabdominal pain that radiated to the back. A CT scan revealed a pancreatic body mass that encased the celiac axis, superior mesenteric artery, splenic artery, and the portosplenic and SMV confluence. Initial EUS revealed an approximately 4 cm hypoechoic solid mass with vascular involvement as previously stated. EUS-guided core biopsy was positive for adenocarcinoma. The patient underwent chemoradiation therapy with good response. Follow-up scans revealed a small residual area of cuffing around the celiac artery and the SMA. Radiation oncology requested fiducial placement in the area of concern to allow selective targeting during radiation therapy. The patient was referred for EUS-guided fiducial placement. Procedure At EUS, an irregular mass was identified in the pancreatic body. The mass was hypoechoic and measured approximately 20 mm, somewhat larger than had been suggested on the CT scan. Encasement of the celiac artery and SMA was confirmed on EUS. Once Doppler ultrasound showed no interposed vessels, an EchoTip Ultra Fiducial Needle was used to place three gold fiducials into the center of the lesion. Outcome The fiducials were deployed without difficulty and were well seen on EUS and via fluoroscopy. The patient tolerated the procedure without difficulty and was then referred back to radiation oncology who were able to commence radiation therapy in a highly targeted manner. Dr. Douglas G. Adler is not a paid consultant of Cook Medical. 7.5 MHz EUS image of the residual pancreatic mass. Fiducial needle advanced in a transgastric manner into the lesion. Fluoroscopic image of the fiducial needle after insertion into the lesion. Fluoroscopic image of 3 fiducial markers in the lesion after deployment. cookmedical.com 7

8 NORWAY Procedure We performed first a high-definition gastroscopy using Lugol s solution to demarcate the lateral border of the tumor (Figure 1) and the distance of the proximal and distal tumor border from the dental line was noted. The suspected PET/CT GTV with SUVmax (standardized uptake value) 4.5 >> was identified to be below the tumor marked with fiducials. In (Figure 3), we can see the difference in the planned target volume (PTV) without fiducials (yellow arrow) and with fiducials (red arrow). Khanh Do-Cong Pham, MD Gastroenterology and Internal Medicine Haukeland University Hospital Jonas Lies vei Bergen, Norway Presentation A 55-year-old patient was diagnosed with a low- to moderately-differentiated squamous cell carcinoma in the proximal esophagus and displayed symptoms of dysphagia and odynophagia. On EUS, the tumor was staged to T2N1 with finding of two suspicious lymph nodes ranging from five to seven millimeters. After multidisciplinary team agreement, the suggested treatment was chemotherapy with cisplatinum and 5-fluorouracil (CiFu) and radiotherapy. On computer tomography (CT) and positron emission tomography (PET/ CT), the tumor margin and suspicious lymph nodes could not be identified, and the patient was therefore referred for fiducial placement to mark the tumor margins and lymph nodes. Figure 1 We changed to a linear EUS scope* (EG-3270UK, Pentax, Japan). Based on the distances found on gastroscopy, we placed one fiducial in the submucosa in the proximal and distal tumor border under EUS guidance. The fiducials can be easily seen on EUS (Figure 2). Two fiducials were placed into metastatic lymph nodes. Figure 2 * The EchoTip Ultra Fiducial Needle is labeled for compatibility with a 3.7 mm channel scope. Figure 3 In this particular case, fiducials were very useful to determinate the radiotherapy field since the tumor is otherwise very difficult to detect radiologically. Dr. Khanh Do-Cong Pham and Dr. Nils Idar Glenjen are not paid consultants of Cook Medical. Nils Idar Glenjen, MD Oncologist, Section for Hematology Department of Medicine Haukeland University Hospital Bergen, Norway 8 cookmedical.com

9 Mark the spot for radiation therapy. Preloaded with 4 Fiducial Markers EchoTip Ultra FIDUCIAL NEEDLE Image courtesy of Dr. Marc Giovannini, Paoli-Calmettes Institute, Marseille, France. cookmedical.com 9

10 with COOK MEDICAL 1998 EUS needle introduced EUS needle introduced to the endoscopy market EchoTip endoscopic ultrasound needle 22g launched 2000 Coiled sheath Introduced the coiled sheath to facilitate needle flexibility EchoTip Endoscopic Ultrasound Needle 19g First EUS biopsy needle and CPN needle for pain associated with pancreatitis 2002 Biopsy needle CPN needle Quick-Core Ultrasound Biopsy Needle 1,2 EchoTip Celiac Plexus Neurolysis Needle Also introduced: EchoTip Endoscopic Ultrasound Needle 25g 2004 Cook s signature handle Pioneered a handle for control and stability EchoTip Ultra Endoscopic Ultrasound Needle 10 cookmedical.com

11 EUS-guided cytology brush EchoBrush Endoscopic Ultrasound Cytology 2, Cytology brush 2007 Improved dimpling pattern Patented high-definition dimpling technology EchoTip Ultra Endoscopic Ultrasound Needle with HDFNA 2008 Cook s signature handle added Improved handle design added to CPN needle EchoTip Ultra Celiac Plexus Neurolysis Needle First EUS needle indicated for access EchoTip Ultra HD Ultrasound Access Needle 3, First EUS access needle cookmedical.com 11

12 2010 Entered EBUS market Expanded into endobronchial diagnosis EchoTip Ultra Endobronchial HD Ultrasound Needle 22g 2011 Introduced FNB First EUS FNB needle introduced to the endoscopy market EchoTip ProCore HD Ultrasound Biopsy Needle 19g and 22g 2012 FNB 25g needle Extended ProCore product line EchoTip ProCore HD Ultrasound Biopsy Needle 25g 2013 EBUS FNB EBUS FNA 25g First EBUS FNB needle and EBUS FNA 25g EchoTip ProCore Endobronchial HD Biopsy Needle 22g and 25g EchoTip Ultra Endobronchial HD Ultrasound Needle 25g 12 cookmedical.com

13 EUS Fiducial needle preloaded with 4 markers 2013 Preloaded Fiducial needle EchoTip Ultra Fiducial needle 22g ReCoil Stylet is introduced 2015 ReCoil stylet EchoTip ProCore HD Ultrasound Needle 20g with ReCoil Stylet COMING SOON Cook will continue its innovative role, working constantly to expand the capability of EUS procedures. Disclaimer: Dates are based on year of first product availability. Not all products are available in all markets. Some products are no longer available. 1st indicates a market first. References: 1. EUS-guided tissue acquisition: an evidence-based approach (with videos), Wani, S et al Gastrointestinal Endoscopy Vol. 80, No EUS accessories, 2007 Gastrointestinal Endoscopy Vol. 66, No Devices for use with EUS, Hwang, JH et al VideoGIE Vol. 2, No Devices for endoscopic ultrasound-guided tissue acquisition, Muniraj, T et al Techniques in Gastrointestinal Endoscopy Vol. 2, No. 9 cookmedical.com 13

14 Cytology, cell block or core: Results you can see. Cytology Cell Block Core EchoTip ProCore HD ULTRASOUND BIOPSY N EEDLE EchoTip Ultra ENDOSCOPIC ULTRASOUND NEEDLE Pathology images courtesy of James Farrell, MD Interventional Endoscopy and Pancreatic Diseases Section of Digestive Diseases, Yale University School of Medicine. 14 cookmedical.com

15 A clinical partnership: Cook Medical s role in EUS Barry Slowey President, Cook Medical s Endoscopy Specialty The last twenty years have seen remarkable advances spanning the spectrum of health care and technology. Ultrasound capabilities in GI endoscopy are not least amongst these. Cook Medical is pleased to have had a role in the EUS revolution beginning in 1998 with our first EUS needle launch. Made possible by years of research and development efforts and direct physician collaboration, our initial EUS-FNA market entry opened the door to advancing capabilities (see EUS innovation timeline, pages 9-12). We invite you to celebrate this anniversary milestone with us along with our continued commitment to the patient care contributions of EUS device innovation. Thanks to all of you who have made these past 20 years of successful EUS collaboration possible. On behalf of all of us at Cook Medical, we look forward to a future of inspired innovation and bright promise for our patients and their families. cookmedical.com 15

16 2018 EVENTS NOVEMBER DECEMBER 1-4 JDDW Kobe, Japan APDW 2018 Seoul, Korea 5-8 Gastro 2018 Bangkok, Thailand rd Int l Workshop/Therapeutic Endoscopy Hong Kong NYSGE New York, New York Live Endoscopy Amsterdam, Netherlands JANUARY FEBRUARY 2019 EVENTS Cedars-Sinai International Endoscopy Symposium Los Angeles, California MARCH st Düsseldorf International Endoscopy Symposium Düsseldorf, Germany th Sydney International Endoscopy Symposium (SIES) Cook Medical Cook Medical CookMedicalEndoscopy CookMedicalEndoscopy An official publication of Cook Medical Bethania Station Rd, Winston-Salem, NC If you would like to submit material for The Channel, please us at thechannel@cookmedical.com. We welcome your comments and suggestions. Disclaimer: The information, opinions and perspectives presented in The Channel reflect the views of the authors and contributors, not necessarily those of Cook Medical. COOK 10/2018 ESC-D42082-EN-F